Nabi-HB (hepatitis B immune globulin)
/ ADMA Biologics
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August 15, 2021
ADMA Biologics Announces Commercial Availability of Expanded Vial Size Offerings for BIVIGAM and NABI-HB
(GlobeNewswire)
- "ADMA Biologics, Inc...announced the commercial availability of additional vial sizes of BIVIGAM and NABI-HB, which are currently in stock and commercially available to U.S healthcare providers and patients...NABI-HB 1 mL and 5 mL vial sizes are available to U.S. healthcare providers and patients and, at the present time, ADMA expects continuous supply availability of both vial sizes going forward."
Commercial • Hepatitis B • Infectious Disease
August 09, 2021
"$ADMA ADMA Biologics Announces Commercial Availability of Expanded Vial Size Offerings for BIVIGAM® and NABI-HB® https://t.co/K7ucSOmxFV #offering"
(@stock_titan)
April 13, 2021
ADMA Biologics Announces Poster Presentation Highlighting Pharmacoeconomic Burden of HIV and HBV Infection in Sexual Assault Patients at the 2021 Academy of Managed Care Pharmacy Virtual Annual Meeting
(GlobeNewswire)
- "ADMA Biologics, Inc....today announced a poster presentation at the 2021 Academy of Managed Care Pharmacy Virtual Annual Meeting ('AMCP') taking place April 12-16, 2021. 'Current CDC guidelines for post-exposure prophylaxis of suspected Hepatitis B infection ('HBV') offer no intervention for sexual assault victims with perpetrators of unknown Hepatitis B surface antigen status,'...'specifically mandating a Hepatitis B Globulin intervention like ADMA’s Nabi-HB hyperimmune, will provide a cost-effective strategy for prophylactic seroprotection of these vulnerable patients.'"
HEOR • Hepatitis B • Infectious Disease
April 11, 2021
[VIRTUAL] PHARMACOECONOMIC ANALYSIS COMPARING MEDICAL COSTS FOR PROPHYLAXIS OF HIV AND HBV INFECTION IN SEXUAL ASSAULT PATIENTS
(AMCP 2021)
- "Compared to patients with acute, chronic, and PEP HIV, medical costs for patients with acute, chronic, and PEP HBV are higher. PEP intervention with a hepatitis B immune globulin (HBIG) that has demonstrated efficacy in preventing HBV infection after exposure may provide immediate protective serum concentrations of anti-hepatitis B antibody that cannot be provided by vaccine administration. Revising CDC guidelines to include HBIG intervention in the CDC recommendations for HBV PEP can protect patients from the risk of HBV infection and reduce healthcare expenditures across managed care organizations"
Clinical • HEOR • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease
August 08, 2019
ADMA Biologics Reports Second Quarter and First Half 2019 Financial Results
(GlobeNewswire, ADMA Biologics, Inc.)
- “We are pleased with our significant accomplishments reported during the second quarter of 2019, which include two United States Food and Drug Administration (“FDA”) approvals, BIVIGAM® and ASCENIV™, as well as the FDA authorizations of product license transfers for BIVGAM® and Nabi-HB®,” stated Adam Grossman, ADMA’s President and Chief Executive Officer. “During the second quarter, we completed an equity financing of approximately $52 million in gross proceeds, which we expect to use to support the commercial inventory build and product launches for BIVIGAM® and ASCENIV™, expand the manufacturing capacity of our Boca Raton, FL facility, the procurement of raw materials, plasma center expansion, other capital expenditures and for general corporate purposes.” . Obtained FDA approval for ASCENIV™ (formerly RI-002). Received FDA approval for license transfers for BIVIGAM® and Nabi-HB®....Commercial launches and sales of BIVIGAM® and ASCENIV™ in second half of 2019."
Commercial • Launch • Regulatory
July 08, 2019
ADMA Biologics Receives FDA Approval for License Transfers for BIVIGAM® and Nabi-HB®
(GlobeNewswire, ADMA Biologics, Inc.)
- "ADMA Biologics, Inc....announces the United States Food and Drug Administration (“FDA”) has notified ADMA the licenses for BIVIGAM® and Nabi-HB® have been revoked from Biotest Pharmaceuticals Corporation, (“BPC”) U.S. License No 1792 and transferred and issued to ADMA’s U.S. License No 2019. “We are very pleased to announce the U.S. License transfer of BIVIGAM® and Nabi-HB® from BPC to ADMA, as this was the final remaining regulatory item from the acquisition of the Biotest Therapy Business Unit transaction,” stated President and Chief Executive Officer, Adam Grossman....Going forward, ADMA will manufacture and introduce both BIVIGAM® and Nabi-HB® into interstate commerce under ADMA’s U.S. License No. 2019..."
Clinical • Commercial • FDA event • Regulatory
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